Clinical research sites
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EHREHR to EDC integration: what a research site checks first
Mount Sinai now fills about 70% of eCRF data from Epic automatically. What EHR to EDC changes for a site, what FDA expects, and what to ask first.
FDAInvestigator responsibilities under 21 CFR 312: what changes
FDA plans a December 2026 proposal to rewrite investigator responsibilities in 21 CFR 312 subpart D. Today's duties, the record for each, and what FDA has said.
Site activationHow to become a clinical trial site: ARPA-H's STACK push
ARPA-H's STACK project aims to turn research-naive practices into trial sites. What a first-time site needs on file before a sponsor or an AI tool arrives.
Latest
Older posts →- EHR
EHR to EDC integration: what a research site checks first
Mount Sinai now fills about 70% of eCRF data from Epic automatically. What EHR to EDC changes for a site, what FDA expects, and what to ask first.
- FDA
Investigator responsibilities under 21 CFR 312: what changes
FDA plans a December 2026 proposal to rewrite investigator responsibilities in 21 CFR 312 subpart D. Today's duties, the record for each, and what FDA has said.
- Site activation
How to become a clinical trial site: ARPA-H's STACK push
ARPA-H's STACK project aims to turn research-naive practices into trial sites. What a first-time site needs on file before a sponsor or an AI tool arrives.
ParticipantsClinical trial participant payments: rules for sites
Clinical trial participant payments under FDA guidance, the OIG's 2026 anti-kickback request for information and the $2,000 Form 1099-MISC line for 2026.
FDAInvestigational product accountability: what FDA checks
Investigational product accountability after FDA's July 2026 warning letter: what 312.62(a) requires, what FDA cites, and a four-way check for sites.
Site operationsClinical trial site burden: measure it before a sponsor asks
Bain's 2026 survey says twice as many sites expect capacity to worsen. Five numbers a research site can count on its own studies to show where the hours go.
NIHSharing study results with participants: NIH's draft policy
NIH's draft policy would require plain-language results for participants in NIH-supported research. What a site records now; comments close October 26, 2026.
FDAFDA single IRB requirement: what a research site prepares
FDA's single IRB rule for multisite studies is listed for December 2026 and takes effect a year after it publishes. What a research site prepares now.
- EHR
EHR to EDC integration: what a research site checks first
Mount Sinai now fills about 70% of eCRF data from Epic automatically. What EHR to EDC changes for a site, what FDA expects, and what to ask first.
- FDA
Investigator responsibilities under 21 CFR 312: what changes
FDA plans a December 2026 proposal to rewrite investigator responsibilities in 21 CFR 312 subpart D. Today's duties, the record for each, and what FDA has said.
- Participants
Clinical trial participant payments: rules for sites
Clinical trial participant payments under FDA guidance, the OIG's 2026 anti-kickback request for information and the $2,000 Form 1099-MISC line for 2026.
Regulatory
All 6 in regulatory →- FDA
FDA single IRB requirement: what a research site prepares
FDA's single IRB rule for multisite studies is listed for December 2026 and takes effect a year after it publishes. What a research site prepares now.
RegulatoryClinicalTrials.gov results reporting: the site's deadlines
ClinicalTrials.gov results reporting falls on the responsible party. When that is your own investigator, here are the two dates and the checks to run.
FDAFDA inspection of a clinical trial site: the 2026 guide
How an FDA inspection of a clinical trial site runs in 2026, what FDA cited at sites in FY 2024, and what a research site prepares before the phone call.
Site operations
All 5 in site operations →- EHR
EHR to EDC integration: what a research site checks first
Mount Sinai now fills about 70% of eCRF data from Epic automatically. What EHR to EDC changes for a site, what FDA expects, and what to ask first.
- Site operations
Clinical trial site burden: measure it before a sponsor asks
Bain's 2026 survey says twice as many sites expect capacity to worsen. Five numbers a research site can count on its own studies to show where the hours go.
- NIH
Sharing study results with participants: NIH's draft policy
NIH's draft policy would require plain-language results for participants in NIH-supported research. What a site records now; comments close October 26, 2026.
- FDA
Investigational product accountability: what FDA checks
Investigational product accountability after FDA's July 2026 warning letter: what 312.62(a) requires, what FDA cites, and a four-way check for sites.
ProtocolProtocol amendment implementation at a research site
Protocol amendment implementation leaves sites on two versions for 215 days on average. The site's cutover list: IRB, training, re-consent, documents.
- FDA
FDA inspection of a clinical trial site: the 2026 guide
How an FDA inspection of a clinical trial site runs in 2026, what FDA cited at sites in FY 2024, and what a research site prepares before the phone call.
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About this section
Written by Mir, Founder, Analytica Solutions. Every number has a named source; every post says what to do about the problem it describes.